Who's Paying For This?
24/03/11 14:04 Filed in: GenomeWeb Daily Scan
Submitted by S. Pelech - Kinexus on Thu, 03/24/2011 - 14:04.
One of the dilemmas confronting drug comparative effectiveness research, apart from who is going to pay for it, is its usefulness once personalized medicine really starts to take hold. The vast majority of drugs are rejected following clinical trials due to issues related to efficacy and toxicity. Often, only a small segment of a trial's participants may benefit or be adversely affected. Humans can be very divergent in their responses to drugs due to individual genetic and environmental differences. As the pharmaceutical industry increasingly integrates biomarker evaluation as a critical component of clinical trials, it will become less important of how the "average" person will react to two competing medicinal drugs for the same disease indication. Rather, it will matter more how well the drug matches the biomarker profile of the person who needs medication.
It is probably inappropriate for the NIH or any other government-related health research institute to be involved in conducting clinical trials of drugs that are being developed by the pharmaceutical industry that have large commercial markets. Some justification exists for government-sponsored trials of drugs for treatment of rare diseases. However, even in this case, there is a moral question of whether greater good arises from focusing on those diseases that cause the greatest suffering to the world's populations on the whole.
Link to the original blog post.
One of the dilemmas confronting drug comparative effectiveness research, apart from who is going to pay for it, is its usefulness once personalized medicine really starts to take hold. The vast majority of drugs are rejected following clinical trials due to issues related to efficacy and toxicity. Often, only a small segment of a trial's participants may benefit or be adversely affected. Humans can be very divergent in their responses to drugs due to individual genetic and environmental differences. As the pharmaceutical industry increasingly integrates biomarker evaluation as a critical component of clinical trials, it will become less important of how the "average" person will react to two competing medicinal drugs for the same disease indication. Rather, it will matter more how well the drug matches the biomarker profile of the person who needs medication.
It is probably inappropriate for the NIH or any other government-related health research institute to be involved in conducting clinical trials of drugs that are being developed by the pharmaceutical industry that have large commercial markets. Some justification exists for government-sponsored trials of drugs for treatment of rare diseases. However, even in this case, there is a moral question of whether greater good arises from focusing on those diseases that cause the greatest suffering to the world's populations on the whole.
Link to the original blog post.